According to the “Wall Street Journal” report, the key ingredients of the United States` first possible officially recognized new coronavirus vaccine were actually in the hands of a family business in a rural Austria.
The above-mentioned family business has only 90 employees, which seems to once again highlight the fragility of the potential vaccine supply chain.
The core material of the new crown vaccine is actually in the hands of a small company
It is reported that the Austrian company is called Polymun, and it is one of the few manufacturers of lipid nanoparticles in the world. Lipid nanoparticles are often used to deliver genetic material to the tiny blood vessels in the body. For many years, it has been mainly used to provide new forms of treatment for cancer, and now it is mainly used for the development of new coronavirus vaccines.
Lipid nanoparticles are one of the key materials for the manufacture of mRNA vaccines, and the new coronavirus vaccines being developed by Pfizer and German biotech companies must also use it. These two vaccines are currently undergoing clinical trials and are in a leading position in the global new crown vaccine development competition.
These vaccines are made of genetic material and need to be protected with lipid nanoparticles before being injected into the patient. Previously, apart from the most cutting-edge fields of medical research, it was rare to hear that other fields have a high urgent demand for lipid nanoparticles. The same is happening in other areas of the vaccine and virus detection supply network, such as refrigeration equipment, certain special chemicals, and medical-grade glass.
In September of this year, Pfizer’s CEO Eberle and German biotechnology company CEO Shaxin took a special plane from Pfizer to investigate the Polymun headquarters in Klosterneuburg, Austria. Subsequently, Pfizer and German biotechnology company reached a production cooperation agreement with Polymun.
It is understood that Pfizer and German Biotech will apply for official recognition of their new coronavirus vaccine in the United States and Europe in November this year, and plan to put it on the market before the end of the year. The two companies' new coronavirus vaccine research and development work is nearing completion, and the success of clinical trials and official recognition will affect their future prospects. At present, these two companies have obtained huge orders of nearly 500 million doses worldwide, which means that once approved, they will take up to several months to complete the delivery task.
Limited capacity to expand production scale, limiting global share
There are many factors that limit the large-scale production of new coronavirus vaccines by these two companies. One of the key reasons is the limited ability of Polymun to rapidly expand production scale. The company’s CEO Dietmar Kadinger said, “The technology used by the company is complex and niche, which makes it difficult to find qualified employees to handle it, and it is difficult to train people with adjacent expertise.” He also He added, "It's like retraining metalworking workers. The principles may seem similar, but this transition takes time. So far, few people have participated in this new technology."
At the same time, Kardinger also said that because the company relies heavily on internal scientific and technological personnel, when three employees take parental leave, the company's production has been affected to a certain extent. Polymun shares some expertise with Pfizer as a way to increase production capacity. Now, Polymun employees are overseeing the production of lipid nanoparticles by the pharmaceutical giant Pfizer.
According to Pfizer's media public relations, in order to build a new coronavirus vaccine supply network, the company is establishing a production and supply process at its factories in Europe and the United States. The spokesperson said, "This is a common practice during the technology transfer period and has high value."
In terms of transportation, Polymun needs to use a dedicated carrier (another potential bottleneck in the supply chain) to transport its products by truck to the Pfizer plant in Belgium, and then send the finished drugs to the world from there.
COVID-19 makes small companies the focus of attention
Professor Luigi Battaglia from the University of Turin, Italy, said that researchers have conducted extensive studies on lipid nanoparticles, but few companies use them for commercial production. Because gene-based therapy is still a new field in pharmacology, it has not been widely used. With the new coronavirus pandemic, many technologies in the medical field have suddenly reordered, and small companies such as Polymun and German biotechnology companies have also become the focus of attention.
It is understood that Polymun was founded in 1992 by Kadinger's father. It faces very limited direct competition. Its rivals are Canada`s Acuitas Therapeutics and the United States` Avanti Polar Lipids. Because of this, Polymun still maintains cooperation with many companies and institutions that are conducting research and development of new coronavirus vaccines. For example, Arcturus Therapeutics in the United States, CureVac AG in Germany, and Imperial College London in the United Kingdom.
Moderna, headquartered in the United States, is also developing mRNA vaccines and is now producing lipid nanoparticles in-house.
Nenad Swichkapa is a researcher at the University of Oxford, UK, specializing in oligonucleotide therapy, including mRNA platforms. In an interview, Nenad said: “Before the outbreak of the new coronavirus, the few companies that focused on the production of lipid nanoparticles could meet the requirements for the development of mRNA vaccines. However, as the new coronavirus spreads, the world’s The demand is beyond imagination, causing some production companies to postpone the delivery of orders."
Adhere to the small-scale development model and refuse to go public or transfer
Herman Kardinger, 80, is the founder of Polymun. He retired in 2009 and gave power to his son. Cardinger and his son are very conservative people, they refused the company's listing or transfer. The company employs about 90 people, but few resign.
Andreas Wagner has been the company's chief scientist since 2001. In his doctoral thesis, he elaborated on a technology he developed that would become one of its key manufacturing processes, and the project itself was funded by Polymun.
But Kardinger doesn't think the company's short size and tight team are weaknesses. He believes that on the contrary, Polymun's scale and cohesion make it highly innovative and non-disclosure, both of which are valuable in the pandemic of stress testing in the medical and pharmaceutical fields.